Systems and methods of microbial sterilization using polychromatic light

ABSTRACT

The present invention is a device for sterilizing microorganisms on a liquid or solid substrate. The device includes a light source for producing a light and an optical device positioned proximate the light source. The optical device is configured to focus the light generated by the light source to provide a high intensity light output. The optical device also includes a dichroic reflector. The dichroic reflector is configured to pass thermal energy generated by the light source and reflect the light produced by the light source. The device also includes a power supply, where the power supply is coupled to the light source and the optical device. The device thereby killing microbial organisms presented within the range of the high intensity light output.

This application is a continuation of U.S. non-provisional patentapplication Ser. No. 15/712,559 filed on Sep. 22, 2017 which is acontinuation-in-part of U.S. non-provisional patent application Ser. No.15/223,909 filed on Jul. 29, 2016 now U.S. Pat. No. 9,801,966 issued onOct. 31, 2017 which is a continuation-in-part of U.S. non-provisionalpatent application Ser. No. 14/815,519 filed on Jul. 31, 2015, nowabandoned, which are incorporated herein in their entirety by reference.

COPYRIGHT NOTICE

A portion of the disclosure of this patent contains material that issubject to copyright protection. The copyright owner has no objection tothe reproduction by anyone of the patent document or the patentdisclosure as it appears in the Patent and Trademark Office patent filesor records, but otherwise reserves all copyright rights whatsoever.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a device for sterilizingmicroorganisms. In particular, it relates to a device for treatment of apatient for the purpose of killing microorganisms.

Description of Related Art

Microbiological sterilization has been pivotal in the production ofbiological products with extended storage times. Various technologieshave been developed to achieve this sterilization, includingUV-irradiation, gamma-ray irradiation (or gamma irradiation), chemicalsterilization, heat sterilization, autoclaving, and ultrafiltration.Because these technologies destroy microorganisms, they are inherentlydamaging to other biological components that may be in the product to besterilized. In light of this fact, a particular technology may notalways be acceptable for sterilizing a given biological product.Recently, an increase in the number and variety of biotechnologyproducts has created a need for adequate sterilization without thedamaging side-effects to the desirable components of the product. Thesebiotechnology products are often extremely labile, requiring specialhandling and storage conditions to retain their activity. Of thesterilizing technologies previously cited, several are not acceptablefor these biotechnology applications. Chemical sterilization, heatsterilization, and autoclaving all damage or alter biological molecules,rendering them inactive. The inactivation of biological moleculeseffectively kills the microbe that utilized these molecules for lifeprocesses. However, this inactivation of biological molecules thatoccurs with prior art technologies is inherently problematic in that itmay also inactivate the desired molecule or molecules contained in thebiotechnology product, thus defeating the purpose of the sterilization.

Ultrafiltration, a recent technology relative to the others mentionedhere, requires the use of filters with a very minute pore-size (at least<0.45 microns). These filters are an inherently slow means ofsterilization, and may not be suitable for solutions of high viscosityor solutions that contain desirable particles, such as cells, that arelarger than the pore diameter and, consequently, too large to passthrough the filter. Gamma-irradiation is a technology not commonly usedfor microbial sterilization, although it can be used to ensure thesterility of the majority of, if not all, biotechnology products. Onemajor reason for its lack of widespread use for microbial sterilizationis that it utilizes a radiation source, such as radioactive cobalt, thatis very radioactive, and thus, very dangerous. This technology requiresextensive shielding and control systems to prevent accidental exposureto operators and others. These protective requirements are economicallyexpensive, often prohibitively so. Therefore, gamma-irradiation is oftennot an economically acceptable technology or a safe technology forsterilization of biotechnology products. Additionally, gamma-irradiationsterilizes products by lysising the biological molecules contained inmicroorganisms. This photochemical mechanism of sterilization may alsodegrade the desired product, rendering it inactive, and thus defeatingthe purpose of the sterilization.

UV-irradiation has been used extensively for microbial sterilization. UVlight breaks the hydrogen bonds between adenine-thymine moieties in theDNA polymer that comprises the genome of the cell or virus, andcatalyzes the formation of a cyclobutane dimer between adjacent thyminemoieties. This disruption of the genome blocks the replication cycle ofthe cell or virus, effectively inhibiting growth of the organism.

Generally, devices that use UV light to sterilize products are composedof a power supply (ballast), a UV light source, a light-focusing and/orlight-conducting device, a light filter, and a control system to assureproper operation. The ballast is designed to supply power to the lamp ina reliable fashion in order to ensure continuous optimal function of thelamp. A variety of UV light sources exist and are known in the priorart, including pulsed, gas-filled flash lamps, spark-gap dischargedapparatus, or low-pressure mercury vapor lamps. Traditionally,low-pressure mercury vapor lamps have been used for microbialsterilization devices because these lamps are relatively inexpensive tooperate and emit relatively higher amounts of UV irradiation than othersources. Other types of vapor lamps are also used, includingmercury-xenon (HgXe) lamps. In particular, a preferred embodiment,according to the present invention, employs a pencil type Hg(Ar)spectral calibration lamp. These lamps are compact and offer narrow,intense emissions. Their average intensity is constant and reproducible.They have a longer life relative to other high wattage lamps. Hg(Ar)lamps of this type are generally insensitive to temperature and requireonly a two-minute warm-up for the mercury vapor to dominate thedischarge, then 30 minutes for complete stabilization.

By way of background, light is conventionally divided into infraredlight (780 nm to 2600 nm), visible light (380 nm to 780 nm), near UVlight (300 nm to 380 nm), and far UV light (170 nm to 300 nm). Most UVlamp sources emit light at discrete wavelengths and include filters tofilter out or block wavelengths other than the specific UV wavelength,especially 254 nm. In the UV region, the most notable UV emission occursat 254 nm. It is known that mercury vapor lamps emit radiation at 254nm. This wavelength can damage the genome of cells and viruses, thusinhibiting their replication, thereby sterilizing the cells and viruses.Therefore, generally in the prior art, a single wavelength detector,tuned to 254 nm, has been used to determine the amount of UV radiationreaching the target. In order to optimize the UV light output efficiencyof the lamp source, at least one filter was interposed in the light pathin order to block non-UV light from reaching the target, allowing onlyUV and proximate-UV light to reach to target. Therefore, the industryhas evolved over time with the solidly established paradigm that 254 nmis the sole and exclusive wavelength of importance for UV sterilization.As such, the prior art teaches away from the inclusion of non-UVwavelength light for microbial sterilization apparatus. Furthermore,this paradigm not only teaches that polychromatic or broad spectrumlight as irrelevant or unimportant, but disadvantageous.

In sharp contrast to UV irradiation, which utilizes a photo thermaland/or photochemical mechanism, Dunn (U.S. Pat. No. 4,871,559, issuedOct. 3, 1989 to Dunn et al., titled METHODS FOR PRESERVATION OFFOODSTUFFS) teaches that the inactivation of enzymes by visible andinfrared radiation utilizes a photo thermal mechanism. When applied athigh-intensity and in combination, UV, IR, and visible light, which arecomponents included in a complete spectrum, result in significant shelflife and stability enhancements of food products by the killing ofmicrobes and by the inactivation of degradatory enzymes. Notably, theprior art for UV sterilization in biotechnology applications teachesaway from Dunn's approach to multiple component light application; sincethe prior art teaches that filtered UV light is desirable whilenonfiltered UV light is undesirable for sterilization of microorganisms,prior art teaches away from the use of non-filtered UV light for thesterilization of microorganisms. Disadvantageously, the activities ofbiotechnology products are frequently based on enzymatic activity orrequire the tertiary or quaternary structure of proteins for activity.Therefore, sterilization techniques like Dunn, that indiscriminatelydegrade proteins and enzymes in the process of sterilization, are notacceptable for use with biotechnology products. Thus, there remains aneed for a sterilization technique that can effectively sterilize abiological product without denaturing the active biological products.

Therefore, there remains a need not solved by the prior art to moreeffectively sterilize a biological product of microorganisms withoutexcessive denaturing of the active biological molecules.

BRIEF SUMMARY OF THE INVENTION

Accordingly, it has been discovered that a dichroic reflector utilizedwith a UV light source can overcome the limitations of the prior art.Therefore, the embodiments of the invention include the following.

In one embodiment, there is a system for sterilizing microorganisms on aheat sensitive liquid or solid substrate, the system comprising:

-   -   a) a high intensity light source for producing a UV light;    -   b) a dichroic reflector positioned proximate the light source,        wherein the dichroic reflector is configured to focus the        reflected light produced by the light source to a first end of        light guide wherein the light guide delivers the light at a        second end to provide a high intensity light output to the        liquid or solid substrate; and wherein the dichroic reflector is        configured to pass thermal energy produced by the light source        through the dichroic reflector; and reflect the light produced        by the light source to the light guide;    -   c) a power supply, wherein the power supply is coupled to the        light source;    -   d) the light guide for receiving the high intensity light output        focused from the dichroic reflector and deliver it from the        light guide second end to the heat sensitive liquid or solid;        and        wherein the microorganisms within the range of the high        intensity light output from the light guide are killed.

BRIEF SUMMARY OF SOME EXAMPLE EMBODIMENTS

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential characteristics of the claimed subject matter, nor is itintended to be used as an aid in determining the scope of the claimedsubject matter.

One example embodiment includes a device for sterilizing microorganisms.The device includes a light source for producing a light and an opticaldevice positioned proximate the light source. The optical device isconfigured to focus the light generated by the light source to provide ahigh intensity light output. The optical device also includes a dichroicreflector. The dichroic reflector is configured to pass thermal energygenerated by the light source and reflect the light produced by thelight source. The device also includes a power supply, where the powersupply is coupled to the light source and the optical device. The devicethereby killing microbial organisms presented within the range of thehigh intensity light output.

In one embodiment, the microbiological sterilization device includes aflexible fluid-core light guide. The flexible fluid-core light guideincludes a first end and a second end. The flexible fluid-core lightguide also includes a tubular body. The light guide is configured to bepositioned and connected with the first end proximate to the opticaldevice such that the high intensity light output is configured to befocused into the first end of the fluid-core light guide and channeledthrough the tubular body toward and out through the second end onto thesubstrate to be sterilized.

Another example embodiment includes a method for providingmicrobiological sterilization. The method includes providing a devicefor sterilizing microorganisms. The device includes a polychromaticlight source for producing a polychromatic light and an optical devicepositioned proximate the polychromatic light source. The optical deviceis configured to focus the polychromatic light generated by thepolychromatic light source to provide a high intensity light output ofapproximately 0.5 J/cm². The optical device also includes a dichroicreflector. The dichroic reflector is configured to pass thermal energygenerated by the light source and reflect the light produced by thelight source. The device also includes a power supply, where the powersupply is coupled to the polychromatic light source and the opticaldevice. The method also includes activating the polychromatic lightsource for a predetermined period of time to provide an exposure periodgreater than approximately 0.01 seconds. The method further includespositioning the device a predetermined distance from a substrate to betreated. The method additionally includes exposing the substrate to betreated to the high intensity light output. The method moreover includesdeactivating the polychromatic light source, having sterilized anymicrobiological agents existing on the substrate.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of some example embodiments of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof, which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates a side view of the device for microbialsterilization.

FIG. 2 is a flowchart illustrating a method for providingmicrobiological sterilization.

DETAILED DESCRIPTION OF THE INVENTION

References will now be made to the figures, wherein like structures willbe provided with like reference designations. It is understood that thefigures are diagrammatic and schematic representations of someembodiments of the invention, and are not limiting of the presentinvention, nor are they necessarily drawn to scale.

While this invention is susceptible to embodiment in many differentforms, there is shown in the drawings, and will herein be described indetail, specific embodiments, with the understanding that the presentdisclosure of such embodiments is to be considered as an example of theprinciples and not intended to limit the invention to the specificembodiments shown and described. In the description below, likereference numerals are used to describe the same, similar orcorresponding parts in the several views of the drawings. This detaileddescription defines the meaning of the terms used herein andspecifically describes embodiments in order for those skilled in the artto practice the invention.

Definitions

The terms “about”, “essentially” and “approximately” mean ±10 percent.

The terms “a” or “an”, as used herein, are defined as one or as morethan one. The term “plurality”, as used herein, is defined as two or asmore than two. The term “another”, as used herein, is defined as atleast a second or more. The terms “including” and/or “having”, as usedherein, are defined as comprising (i.e., open language). The term“coupled”, as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

The term “comprising” is not intended to limit inventions to onlyclaiming the present invention with such comprising language. Anyinvention using the term comprising could be separated into one or moreclaims using “consisting” or “consisting of” claim language and is sointended.

References throughout this document to “one embodiment”, “certainembodiments”, and “an embodiment” or similar terms means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment of thepresent invention. Thus, the appearances of such phrases in variousplaces throughout this specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments without limitation.

The term “or” as used herein is to be interpreted as an inclusive ormeaning any one or any combination. Therefore, “A, B or C” means any ofthe following: “A; B; C; A and B; A and C; B and C; A, B and C”. Anexception to this definition will occur only when a combination ofelements, functions, steps or acts are in some way inherently mutuallyexclusive.

The drawings featured in the figures are for the purpose of illustratingcertain convenient embodiments of the present invention, and are not tobe considered as limitations thereto. The term “means” preceding apresent participle of an operation indicates a desired function forwhich there is one or more embodiments, i.e., one or more methods,devices, or apparatuses for achieving the desired function and that oneskilled in the art could select from these or their equivalent in viewof the disclosure herein and use of the term “means” is not intended tobe limiting.

As used in the specification and the claims, the phrase “configured to”denotes an actual state of configuration that fundamentally ties recitedelements to the physical characteristics of the recited structure. Thatis, the phrase “configured to” denotes that the element is structurallycapable of performing the cited element but need not necessarily bedoing so at any given time. As a result, the phrase “configured to”reaches well beyond merely describing functional language or intendeduse since the phrase actively recites an actual state of configuration.

As used herein, the term “device for sterilizing microorganisms on asolid or liquid substrate” refers to a device that has a light sourceproducing a wide spectrum of light capable of killing a microorganism,such as a bacteria or virus that is on a solid or liquid substrate. Inparticular, it produces a wide UV spectrum (i.e. more than just anisolated wavelength) even though it can produce other spectrums of lightand, in one embodiment, the light produces a high UV output. Solid andliquid substrates refer to non-gas substrates, such as liquids, blood,skin, bone, organs, or inanimate liquids/solids.

As used herein, the term “light source” refers to a bulb of any kindwhich produces a sterilizing UV light. This can be UVA, UVB, UVC, or acombination. Regular bulbs, but also high intensity discharge (HID)bulbs, are also embodiments of the invention. So, for example, a highintensity mercury xenon (HgXe) bulb can be utilized. These types ofbulbs are high UV output bulbs. In general, the light output of somebulbs of the invention are from about 0.1 J/cm² to about 50.0 J/cm². Italso includes arc type lamps when they are focused properly.

As used herein, the term “optical device” refers to a device thatcollects light reflected off of the dichroic reflector and focuses thelight into a high output stream. The focusing creates a high intensitylight output. The device can be electric powered or have a manual way tofocus the light.

As used herein, the term “high intensity light output” refers to lightoutput of about at least 80 lumens per watt output in order to achievethis high intensity light output, one cannot use low or medium pressurelamps that produce UV light, as they do not produce enough light output.An arc discharge lamp produces does not produce the level of lightoutput intensity needed. In order to achieve the high intensity outputneeded, one can add to the arc discharge lamp's light output anelliptical reflector which collimates the polychromatic light into stillgreater intensity (intensity being understood as energy per area) ofabout 100 lumens per watt (i.e. producing the high intensity lightoutput needed).

As used herein, the term “dichroic reflector” refers to any of adichroic focus, reflector, mirror, lens or the like that takes lightfrom the light source and allows some or all of the thermal energy topass through the reflector while taking the light, especially the UVlight, to be reflected for focusing. In one embodiment, there may bemore than one dichroic reflector but at least one must focus the lightto the light pipe. The dichroic reflector can be any shape that works toeither remove heat or focus the light but, in one embodiment, it is anelliptical shape for focusing. In one embodiment, an elliptical dichroicreflector is used with an arc lamp. This is different from a dichroicfilter which only filters or reflects light but does not pass heatwavelengths through it. the dichroic filter can be a powered orunpowered device.

As used herein, the term “power supply” refers to an AC or DC sourcethat powers the light supply and, where needed, the optical device orany other part of the device.

As used herein, the term “polychromatic” refers to light comprisingmultiple wavelengths of light.

As used herein, the term “predetermined exposure period” refers to thetime period that light produced by the device is shown on amicroorganism in order to kill it. In one embodiment, it is from about0.01 seconds to about 5 seconds. In one embodiment, a shutter isutilized to open, close, and modulate the passage of light from thelight source to the microorganism.

As used herein, the term “fluid-core light guide” refers to a lightguide for taking light emitting from the focusing device and helping todeliver it to a product substrate or patient as needed. While the guideis not necessary to use the invention, it is an embodiment that helpsfocus or make it easier to deliver the focused light to a desiredlocation/substrate, patient, or the like. The guide is generally a tubehaving a first and a second end of the tube, wherein the first end isused to collect light outputting from the device when positionedproximate to the device, such that the light channels through the tubeand is delivered to the second end and out thereof, to deliver lightwhere desired e.g. a substrate. The light guide could include acollimator. The light guide can be at least one of: flexible, UVtransmissive, have or be a liquid, have an aqueous salt solution, have ametallic salt solution, wherein, in one embodiment, the metallic salt isNa, K, Mg or combinations thereof, a non-aqueous solution, or a gas.

The present invention relates generally to microbial sterilization (orDNA disruption, DNA inactivation), and more particularly to microbialsterilization using brief pulses of high-intensity polychromatic lightdirected optionally through a flexible, infrared-absorbing light guide.One of the objects of the present invention is to improve on the priorart by more effectively sterilizing a biological substrate, a product,or any substrate of microorganisms without excessive denaturing of anyof the active biological molecules. (e.g. sterilizing microorganisms ona patient body surface). A further object of the present invention isthe use of a shutter mechanism for the modulation of the exposure periodto polychromatic, full spectrum light. A further object of the presentinvention is the use of a dichroic reflector for removal of thermalenergy and the focusing (concentrating) of polychromatic, full spectrumlight. A further object of the present invention is the use of anelectronic circuit board for modulating lamp power, thermals and shuttertimer of polychromatic, full spectrum light.

Thus, it is one aspect of the present invention to provide an apparatusthat will sterilize biological, non-biological, or other products by wayof high-intensity polychromatic or broad spectrum light irradiation,including UV-irradiation. It is another aspect of the present inventionto provide an apparatus using light that has been filtered through afluid to absorb the infrared region of the light spectrum, in order tominimize the photo thermal denaturing of the desirable elements of theirradiated object. We contend that those structures, such as muscle,fat, bone, hair, fluid, plant and fungus structures, are affected bysuch light. Additionally, non-biological materials, such as plastics,are also affected by germicidal light aimed at DNA disruption and ourdesign provides less destructive effects. With the removal of the heatassociated with such treatments, biological surfaces and other surfacesand substrates are spared.

An embodiment of the invention provides a device for microbialsterilization, generally referenced 100, as shown in FIG. 1. FIG. 1shows that the device for microbial sterilization 100 can include: apower supply 102; a UV light source 104; at least one optical device 106(which, in this embodiment, includes a dichroic reflector 108); a lightshutter mechanism 110; a cooling fan 112; a timer 114; a light guide orlight guide-conducting device 116 (that also functions as an infraredlight filter) with a first end 117 a and a second end 117 b; and anexposure control system 118 to assure proper operation. Also featuredare UV-sensitive diodes in a light-screened box 122, a detector circuit124, as well as a neutral density filter and a UV-selective filter 123.FIG. 1 also shows the invisible infrared light (radiated heat) 130, abeam of incident light 129, a microorganism 121, and a substrate 120.The components of the embodiment are configured, positioned, andconnected such that the power supply 102, in this embodiment consistingof an electronic circuit board, provides energy to the system. Inparticular, the power supply provides energy to the UV light source 104,which emits a light that is reflected off the at least one opticaldevice 106, and otherwise focused or directed into the light guide 116.The dichroic reflector 108 provides a means for removing heat from thesystem. The cooling fan 112 provides another means for removing excessheat from the system. The shutter mechanism 110, timer 114, and controlsystem 118 are interconnected to provide a controlled on/off lightoutput which reaches the substrate 120 having microorganisms 121.

In one embodiment, the present invention includes a power supply 102consisting of an electronic circuit board; a mercury xenon (HgXe) lampas the UV light source 104; an elliptical dichroic reflector 108 in anoptical device 106; a light shutter mechanism 110; a light guide 116that also functions as an infrared light filter; and a control system118. In one embodiment, the power supply 102 consists of a ballast thatprovides electricity at the appropriate voltage and amperage to powerthe ultraviolet (UV) light source 104. In another embodiment, the powersupply 102 consists of a transformer to supply electricity at the propervoltage and amperage to power the UV light source 104. In anotherembodiment, the power supply 102 is an electronic circuit board (PCB)that provides electricity at the appropriate voltage and amperage topower the ultraviolet (UV) light source/lamp 104. The electronic circuitboard connects other electronic equipment to, typically, a lamp igniterassociated with a power supply. The lamp igniter delivers 8-12 amps tostart the lamp. The power supply holds the lamp output withapproximately 3-5 amps for a 100 W Hg or Hg/Xe lamp.

In one embodiment, the UV light source 104 is an HgXe vapor lamp,although other sources of UV light are also envisioned. The HgXe lamp isof a sufficient intensity to supply an energy density of between about0.01 Joules per centimeter squared (J/cm²) to about 50 J/cm² in awavelength of between approximately 170 nanometers (nm) to approximately2600 nm depending on the microorganism 121 to be sterilized. In anotherembodiment, the energy density impinging on the microorganism 121 to besterilized is about 0.5 J/cm². Advantageously, the lamp is cooled by thecontinuous flow of air or a fluid, preferably water, directed over thelamp at a rate sufficient to prevent the lamp from overheating.

Additionally, the dichroic reflector 108 assists in dissipation from thelamp 104. Dichroic reflectors tend to be characterized by the color(s)of light that they are configured to reflect, rather than the color(s)they pass, as opposed to dichroic filters, thin-film filters, orinterference filters, which are very accurate color filterscharacterized by the colors of light they selectively pass. The dichroicreflector 108 can be used behind the light source/lamp 104 to reflectvisible (or other desired) light 129 forward while allowing theinvisible infrared light (radiated heat) 130 to pass out of the rear ofthe device 100, resulting in a beam of light 129 that is literallycooler (of lower thermal temperature) i.e. there is an 80% reduction ofthermals. Such an arrangement allows a given light 129 to dramaticallyincrease its forward intensity while allowing the heat generated 130 bythe backward-facing part of the device 100 to escape. In one embodiment,the dichroic reflector 108 is elliptical shaped. The dichroic surface ofthe reflector 108 is constructed of a sufficient surface coating toallow for the majority of incident light 129 to reflect, while allowingthermal light 130 to pass. The elliptical shape is designed such that amajority of the light emitted by the light source 104 that strikes thereflector 108 is reflected and focused towards the first end 117 a ofthe light-conducting device 116.

Light exposure period modulation has traditionally been done throughmodulating the electrical current to a lamp. This type of exposurecontrol system using electrical current is relatively economical and hastherefore gained wide acceptance. However, continual flashing of thelight source/lamp due to the current being turned on and off isdetrimental to the light source/lamp, and results in a shorter lamplife. Therefore, the light source/lamp 104 is maintained in continuousexcitation during use and light exposure modulation occurs throughshutter mechanism 110. Shutter mechanism 110 can deliver exposureperiods of between about 0.01 seconds to about 5 seconds, preferablybetween about 0.1 seconds and about 3 seconds, more preferably about 3seconds. In addition, the shutter mechanism 110 can deliver theseexposure periods in a repetitive manner in order to achieve a totalexposure time sufficient to sterilize the microorganisms 121. The lowexposure time can be critical to ensure that sterilization occurswithout damaging the underlying substrate 120. Preferably, this exposureinterval is typically in the range from about 0.01 to about 3 seconds,preferably 0.1 seconds.

The light-conducting device 116 is a fluid-core light guide consistingof a tube with a fluid core, having a first end 117 a and a second end117 b. The tube in light guide 116 is a flexible, hollow tube, the wallsof which are composed of a highly reflective material, of at least ashigh or higher reflectivity as the contained fluid itself, therebyincreasing transmissivity within the light guide 116, or at leastmaintaining the transmissivity of the fluid itself. Additionally, thehighly reflective material used in the tube walls has a diffractioncoefficient sufficient such that the majority of light in the 200 nm to1200 nm range transmitted through the fluid core of the tube isreflected back into the fluid core, should it contact the walls of thetube.

In light-conducting device 116 the fluid core is composed of a gas, anaqueous metallic salt solution (or some other aqueous solution), or anon-aqueous solution. The fluid in fluid-core light guide 116 isformulated such that it absorbs infrared light that may be emitted bythe HgXe lamp/light source 104 and transmitted into the fluid-core lightguide 116. In one embodiment, the fluid is a non-aqueous solutioncomposed of organic fluids. Organic fluids are desirable for this usesince they have high infrared (IR) absorptivity, and infrared light candamage the proteins, enzymes and cell components of a microorganism 121,precluding the viability of a sterilized organism for use as a vaccine.In another embodiment, the fluid is an aqueous metallic salt solution,such as an aqueous sodium chloride (NaCl) solution—although the salt mayalso be selected from the group consisting of KCl, MgCl, MgSO₄, otherorganics, and the like. The concentration of NaCI is between about 5% toabout 50%. Preferably, the concentration can range between about 5% toabout 10%.

The ends 117 a and 117 b of the light guide 116 may be fabricated fromtranslucent quartz, fused silica, or synthetic or natural diamond, allof which do not absorb UV light. The light guide 116 directs the exitinglight out of second end 117 b towards the microorganism 121 which is onsubstrate 120. Additionally, a dichroic reflector 108, of an appropriateshape is used to focus reflected light on the microorganism 121 which ison substrate 120 while passing thermal energy 130 away from thesubstrate 120 to prevent damage to the substrate 120 while sterilizingthe microorganism 121.

The proper functioning of the sterilizing device 100 is assured by acontrol system 118. The control system 118 is composed of a UV-sensitivediode placed in a light-screened box 122 juxtaposed to the microorganism121 on the substrate 120. The UV sensitive diode 122 is coupled to adetector circuit 124 that provides an output indicative of the amount oflight impinging upon the UV-sensitive diode 122 during the exposureperiod. A neutral density filter and a UV-selective filter 123 areinterposed between the light guide 116 and the UV-sensitive diode 122 inorder to attenuate the light and to impede passage of wavelengthsoutside the UV range, respectively. In the event that the detectorcircuit 124 detects that the light impinging on the UV-sensitive diode122 is below a sufficient level, the power delivered to the lightsource/lamp 104 (which could be a flash lamp, gas lamp, etc.) may beincreased, the exposure period may be lengthened, or the sterilizationoperation may be suspended until the device 100 can be serviced.

In another embodiment, an alternate means of controlling the amount ofUV light landing on the microorganism 121 on the substrate 120 is to usea control system 118 as above, but instead of measuring the UV lightimpinging on a UV-sensitive diode 122, the detector circuit 124 ispaired with a means to measure the fluorescence emitted by themicroorganism 121. It is understood that fluorescence is a key factor inthe effectiveness of this device for microbial sterilization usingpolychromatic light for inactivation of microorganisms. Fluorescence isan indication of an activated state, and is the result of absorbinghigh-energy radiation that is then emitted at a low energy wavelength.An activated state is believed to be associated with a greater chemicalreactivity, and thus is believed to favor the formation of cyclobutanedimers in the genome of the cell or microorganism.

The device for microbial sterilization 100 according to the presentinvention has virtually unlimited application. By way of example, not oflimitation, the device can be used for the inactivation and orsterilization of all known pathogens, including viruses (such as herpessimplex virus and HIV), bacteria (such as E. coli and Staphylococcusspp.), and fungi (such as Candidiasis) by creating vaccines from thesterilized microorganism(s).

Also advantageously, the device for microbial sterilization 100,according to the present invention, can be used to sterilize remote orlarge fixed substrates. By constructing the device 100 of such materialsand technology as to make the device portable by a person, the device100 can be used to rapidly sterilize remote or large substrate areas. Insuch an embodiment, a person, in this case a sterilizationadministrator, can sterilize a large substrate area with ease by simplymaintaining the direction of the light guide 116 towards the substrateand the moving the light 129 over the substrate area while thesterilization administrator potentially moves or walks around.

FIG. 2 is a flow chart illustrating a method 200 for providingmicrobiological sterilization. The method allows for sterilization ofany desired substrate without damaging structures such as muscle, fat,bone, hair, fluid, plant and fungus structures. In particular, harmfulportions of high intensity light have been eliminated such that theresulting output only damages microorganisms without damaging theunderlying structure.

FIG. 2 shows that the method can include providing 202 a device forsterilizing microorganisms. For example, the device for sterilizingmicroorganisms can include the device 100, reference above with respectto FIG. 1. Therefore, the method 200 will be described, exemplarily,with reference to the device 100 of FIG. 1. Nevertheless, one of skillin the art can appreciate that the method 200 can be used with a deviceother than the device 100 of FIG. 1.

FIG. 2 also shows that the method 200 can include activating 204 thepolychromatic light source for a predetermined period to provide anexposure period greater than about 0.01 seconds. For example, theexposure period can be from 0.01 seconds and about 5 seconds, preferablybetween about 0.1 seconds and about 3 seconds, more preferably about 3seconds. In addition, a shutter mechanism can deliver these exposureperiods in a repetitive manner in order to achieve a total exposure timesufficient to sterilize the microorganisms.

FIG. 2 further shows that the method 200 can include positioning 206 thedevice a predetermined distance from a substrate to be treated. Forexample, the device can be positioned 206 approximately 2.25 inches awayfrom the substrate. The distance can be adjusted based on the substratebeing treated, the intensity of the output, the microorganisms beingsterilized and other facts.

FIG. 2 additionally shows that the method 200 can include exposing 208the substrate to be treated to the high intensity light output. That is,the high intensity light output is directed onto the substrate,sterilizing the microorganisms thereon. The exposure can includeconstant exposure or a “sweep” that moves the high intensity lightoutput along the substrate.

FIG. 2 moreover shows that the method 200 can include deactivating 210the polychromatic light source, having sterilized any microbiologicalagents existing on the substrate. That is, once the microorganisms havebeen sterilized the light source is turned off and the substrate is nowsterilized for the desired use

One skilled in the art will appreciate that, for this and otherprocesses and methods disclosed herein, the functions performed in theprocesses and methods may be implemented in differing order.Furthermore, the outlined steps and operations are only provided asexamples, and some of the steps and operations may be optional, combinedinto fewer steps and operations, or expanded into additional steps andoperations without detracting from the essence of the disclosedembodiments.

Having described the present invention, various aspects of the inventionhaving more specific preferred embodiments and examples will now bedescribed in greater detail by way of the following specific examples.These examples demonstrate quantitatively the effectiveness of theinvention for preserving biotechnology products by reducing oreliminating microorganisms. In these examples, microorganisms weredeliberately introduced into the product to be treated. The deliberateintroduction of high counts of microorganisms to a product results in ahigh degree of self-shielding of the microorganisms, requiring anincreased exposure time to the sterilizing light over routine counts ofmicroorganisms. Therefore, these examples represent a dramaticdemonstration of the effectiveness of the high-intensity lighttreatment.

EXAMPLE 1

This example is based upon an experiment conducted with a fluid-filledlight guide, available commercially from Edmund Scientific®, clamped toa position with the light emitting end of the light guide substantiallyperpendicular to the substrate to be exposed and sterilized,approximately 2.25 inches away from the substrate. The fluid-filledlight guide was connected to an aperture housing and shutter mechanismpositioned in front of and coupled with a light source, in thisexperiment the light source is a high power, 1 kilowatt mercury-xenon(HgXe) lamp, available commercially from the LESCO UV division ofAmerican Ultraviolet©. Herpes virus (HSV) cultures were prepared fromherpes-virus infected cells by dilution of culture supernatant into cellculture media at a dilution sufficient to provide 10⁶ plaque-formingunits (PFUs)/mL. An aliquot of approximately 10 mL was exposed to UVlight, at a distance 2.25″ from the device, according to one embodiment,for a period of 3 seconds. After the exposure period, triplicate samplesof 2 mL were taken from the treated sample and applied to freshlyprepared HSV cells and incubated at 37° C. for 72 hours. Uponexamination at 3 days, no plaques were observed in the treated samples,whereas the positive control samples were observed to have a titer of10⁶ PFUS/mL; thus, at the start of the experiment, 10⁶ PFUs/mL weretreated for 3 seconds in one embodiment, according to the presentinvention, resulting in zero (0) PFUs/mL after exposure with the highintensity light source.

Additionally, a semi-quantitative inactivation of bacteria, and otherviruses, including but not limited to E. coli, Staphylococcus spp., andKlebsiella culture, were sterilized with UV-light. These are set forthby way of example and not of limitation. Other bacteria, like thosecommonly found in households, ventilation, fecal matter, human mouths,and the like, will be similarly inactivated and sterilized when exposedto the device according to the present invention, in a similar mannerand similar conditions to those set forth in Example 1.

Those skilled in the art to which the present invention pertains maymake modifications resulting in other embodiments employing principlesof the present invention without departing from its spirit orcharacteristics, particularly upon considering the foregoing teachings.Accordingly, the described embodiments are to be considered in allrespects only as illustrative, and not restrictive, and the scope of thepresent invention is, therefore, indicated by the appended claims ratherthan by the foregoing description or drawings. Consequently, while thepresent invention has been described with reference to particularembodiments, modifications of structure, sequence, materials and thelike apparent to those skilled in the art still fall within the scope ofthe invention as claimed by the applicant.

What is claimed is:
 1. A method for delivering a high energy UV light toa substrate comprising: a. selecting a high energy light that delivers ahigh energy UV light without thermal energy; and b. delivering the highenergy light without thermal energy to the substrate.